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NCT Number: NCT06768853

The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location contact

Hexiao Tang, PhD

CONTACT

[email protected]

15102723563 ext. +86

About this study

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. Investigators will randomly divide all enrolled patients into an experimental group and a control group. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators will calculate the consistency between preoperative prediction results and postoperative pathological results to verify the accuracy of the model. And investigators will evaluate the impact of this new lymph node dissection method on prognosis by comparing the intraoperative blood loss, postoperative complications, disease-free survival, and overall survival between the two groups of patients. Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range from 18 to 70 years old;
  • Chest CT shows a single pulmonary nodule, which may be adenocarcinoma or squamous cell carcinoma;
  • Chest CT shows multiple pulmonary nodules, but preoperative evaluation suggests that pulmonary nodules other than the main lesion are benign;
  • Preoperative auxiliary examination evaluates the patient as clinically resectable lung adenocarcinoma or squamous cell carcinoma in stages I, II, or IIIA (UICC-TNM 9th edition);
  • ECOG score 0-1;
  • Preoperative lung function FEV1 ≥ 1.0L and actual/expected value ≥ 80%;
  • No contraindications for surgery;
  • Technically, lobectomy or segmental resection combined with lymph node dissection can be performed;
  • Preoperative plain scan and enhanced chest CT examination;
  • The interval between surgery and chest CT, lung function, and electrocardiogram examinations is less than or equal to 28 days;
  • The patient signs a written informed consent form.

Exclusion criteria

  • Chest CT suggests multiple primary lung cancer or metastatic cancer;
  • Previous history of thoracic surgery;
  • Previous history of malignant tumors;
  • History of neoadjuvant therapy;
  • A history of severe heart failure, myocardial infarction, cerebral infarction, and pneumonia within 6 months prior to surgery;
  • Concurrent active bacterial or fungal infections;
  • Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated;
  • Concomitant mental illness;
  • Pregnant/lactating women.

Treatment and study plan

Lymph node dissection based on the guidelines

Procedure

During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .

Lymph node dissection based on the model

Procedure

During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.

Primary outcomes

  1. Consistency rate between preoperative prediction results and postoperative pathological results

    Time frame: 1 week after surgery

    Compare postoperative lymph node pathology results with preoperative prediction results

Secondary outcomes

  1. Postoperative complications

    Time frame: 30 days after surgery

    Observation of complications within 30 days after surgery

  2. Postoperative recurrence rate

    Time frame: 2 years after surgery

    Observe for recurrence within 2 years after surgery

  3. Disease-free survival

    Time frame: 2 years after surgery

    Follow up after surgery to determine if there is any recurrence or metastasis, and calculate disease-free survival

  4. Overall survival

    Time frame: 2 years after surgery

    Follow up after surgery to determine if there is death, and calculate overall survival

  5. Intraoperative blood loss

    Time frame: During the surgery

    Record intraoperative blood loss

  6. Postoperative drainage volume

    Time frame: 2 weeks after surgery

    Record postoperative drainage volume

  7. Postoperative drainage time

    Time frame: 2 weeks after surgery

    Record the time from the end of the surgery to the removal of the drain tube

Study contacts

Contact information is provided by the study sponsor or research team.

Hexiao Tang, PhD

CONTACT

[email protected]

15102723563 ext. +86

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

Clinical Study on Predicting Mediastinal Lymph Node Metastasis in Patients with Lung Cancer by the Predictive Model Based on Clinical Characteristics and Radiomics

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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